Idylla Respiratory (IFV-RSV) Panel— 510(k) K163628

Name: FDA 510(k) clearance K163628
Creator: U.S. Food and Drug Administration
Published: 2017-08-30

Substantially Equivalent

Janssen Pharmaceutica NV

FDA 510(k) clearance K163628 for Idylla Respiratory (IFV-RSV) Panel, Substantially Equivalent on 2017-08-30. Applicant: Janssen Pharmaceutica NV. Device class: 2.

Clearance details

Applicant: Janssen Pharmaceutica NV
Product code: Code OCC
Device class: Class 2
Regulation: 21 CFR 866.3980
Advisory panel: Microbiology
Date received: 2016-12-22
Decision date: 2017-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beerse, BE

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OCC

product code OCC

Death: 3
Malfunction: 706
Total: 709

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.